Word: fda
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Dates: during 1990-1999
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Beta interferon has not been yet approved by the Food and Drug Administration (FDA). Hedison said that Biogen plans to file with the FDA in the beginning...
...fact sheet issued by the campaign says that 31 deaths and more than 1500 serious illnesses "have been attributed to a genetically engineered amino acid called L-tryptophan." The Food and Drug Administration (FDA) failed to regulate the sale of the product because it was not labeled as "genetically engineered," the sheet charges...
...originally conceived, the fast-track process makes a lot of sense. The goal is to streamline the necessary steps toward FDA approval so that they do not take years to complete. One way to accomplish that, the agency decided, was to accept preliminary evidence from small clinical trials rather than wait for final proof from a comprehensive study. Typically the trials consist of a few hundred people and last only a matter of months. In return, the pharmaceutical companies were supposed to conduct follow-up studies that confirmed their drugs' effectiveness after they were out on the market. The FDA...
Under the accelerated approval plan, protease inhibitors could get the go- ahead from the FDA without much fuss within months. But members of the Treatment Action Group think they have a better idea. At this week's meeting of the FDA advisory panel, they plan to propose a large-scale, two-year to five-year study of the protease inhibitors. The study would include 18,000 participants, of whom all would receive standard aids care but only half would get a protease inhibitor; the other half would receive a placebo instead. Because so many people would be involved...
...used to prevent miscarriage, treat prostate and breast cancer or reduce the symptoms of menopause; it can even promote growth in sheep and cows. But in 1971, after studies linked its use by pregnant women with reproductive-system abnormalities, infertility and cancer in their offspring, the FDA decreed that DES should no longer be used to prevent miscarriage. In 1979 the drug was banned in livestock because traces were showing up in meat...